Perhaps we could gain some insight by looking at a case study of XP23829. First off, maybe Cellceutix could learn from their trial design. Seems like it was impossible to miss their Primary Outcome measure. AF would be happy I suppose.
"Primary Outcome Measures:
* • The percent change in PASI (Psoriasis Area and Severity Index) score from Baseline [ Time Frame: 12 Weeks ]
https://clinicaltrials.gov/ct2/show/NCT021733...amp;rank=1
9/15/2015
"XenoPort Announces Positive Phase 2 Study Results for XP23829 as a Potential Treatment for Patients with Psoriasis
Efficacy observed with both 800 mg once-daily and 400 mg twice-daily XP23829 dosing"
"XP23829 was safe and generally well tolerated. There were no deaths or life-threatening adverse events. No subjects met the safety discontinuation criteria and the majority of treatment emergent adverse events were non-serious and mild or moderate in severity. Diarrhea adverse event rates were consistent with other drugs in the fumaric acid ester class ranging from 22% to 40% in the XP23829 treatment groups compared with 15% for placebo. Other treatment emergent adverse events occurring at an incident rate of greater than or equal to 10% were nausea, abdominal pain, vomiting and headache. The incidence of flushing in the XP23829 dose groups was similar to placebo. Gastrointestinal events were the most frequent adverse event leading to withdrawal during XP23829 treatment. There were two treatment emergent serious adverse events assessed as possibly related to treatment with XP23829: acute cholecystitis and enterocolitis. Both subjects recovered."
http://www.businesswire.com/news/home/2015091...dy-Results
2 SAE's but company happy with results? I wonder what the market thinks?
9/15/2015
"XenoPort Shares Dive After Psoriasis Drug Study Results"
" Shares of Santa Clara, CA-based XenoPort were down 25 percent by midmorning Tuesday after the company announced positive preliminary results from a Phase 2 clinical trial of its oral psoriasis drug.
Although the biotech said it expects to begin Phase 3 trials of its drug, XP23829, in 2016, a high rate of gastrointestinal side effects may impede its efforts. XenoPort’s shares had initially been up 19 percent earlier Tuesday morning."
http://www.dddmag.com/news/2015/09/xenoport-s...dy-results
Things look bleak. There are some ugly side effects so what happened?
Imho Prurisol doesn't have to be worth 10 Billion. If Cellceutix had 47 million in the bank they could cover the B and K trials dilution free.
3/28/2016
"-Dr. Reddy's Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY) and XenoPort, Inc. (NASDAQ: XNPT) announced today that they have entered into a license agreement pursuant to which Dr. Reddy’s Laboratories will be granted exclusive U.S. rights for the development and commercialization of XenoPort’s clinical-stage oral new chemical entity, XP23829. Dr. Reddy’s Laboratories plans to develop XP23829 as a potential treatment for moderate-to-severe chronic plaque psoriasis"
"Under the terms of the agreement, Dr. Reddy’s Laboratories will receive exclusive U.S. rights to develop and commercialize XP23829 for all indications. In exchange for these rights, XenoPort will receive a $47.5 million up-front payment and an additional $2.5 million for transfer of certain clinical trial materials to Dr. Reddy’s Laboratories. XenoPort will also be eligible to receive up to $190 million upon the achievement by Dr. Reddy’s Laboratories of certain regulatory milestones, which could be achieved over a period of several years. In addition, XenoPort will be eligible to receive up to $250 million upon the achievement of commercial milestones, and up to mid-teens royalty payments based on potential net sales of XP23829 in the United States."
"“We are very pleased to announce this agreement with Dr. Reddy’s Laboratories,” said Vincent J. Angotti, Chief Executive Officer, XenoPort, Inc. “As one of our key objectives for 2016, we were interested in finding a strong partner that would recognize the opportunity of this innovative therapy that we believe will make a significant difference in the lives of psoriasis and MS patients. "
http://www.businesswire.com/news/home/2016032...-Licensing
They had multiple drugs in development, like Cellceutix, and did end up selling the entire company for what would put Cellceutix at around $4 a share.
5/23/2016
"XenoPort (XNPT) Stock Skyrockets, Arbor Pharmaceuticals Acquiring For $467 Million"
"NEW YORK (TheStreet) -- XenoPort (XNPT) shares are soaring 56.59% to $6.89 Monday on heavy trading volume, following the announcement that Arbor Pharmaceuticals will buy the biopharmaceutical company in a deal valued at around $467 million. "
https://www.google.com/amp/s/www.thestreet.co...llion.html
"Primary Outcome Measures:
* • The percent change in PASI (Psoriasis Area and Severity Index) score from Baseline [ Time Frame: 12 Weeks ]
https://clinicaltrials.gov/ct2/show/NCT021733...amp;rank=1
9/15/2015
"XenoPort Announces Positive Phase 2 Study Results for XP23829 as a Potential Treatment for Patients with Psoriasis
Efficacy observed with both 800 mg once-daily and 400 mg twice-daily XP23829 dosing"
"XP23829 was safe and generally well tolerated. There were no deaths or life-threatening adverse events. No subjects met the safety discontinuation criteria and the majority of treatment emergent adverse events were non-serious and mild or moderate in severity. Diarrhea adverse event rates were consistent with other drugs in the fumaric acid ester class ranging from 22% to 40% in the XP23829 treatment groups compared with 15% for placebo. Other treatment emergent adverse events occurring at an incident rate of greater than or equal to 10% were nausea, abdominal pain, vomiting and headache. The incidence of flushing in the XP23829 dose groups was similar to placebo. Gastrointestinal events were the most frequent adverse event leading to withdrawal during XP23829 treatment. There were two treatment emergent serious adverse events assessed as possibly related to treatment with XP23829: acute cholecystitis and enterocolitis. Both subjects recovered."
http://www.businesswire.com/news/home/2015091...dy-Results
2 SAE's but company happy with results? I wonder what the market thinks?
9/15/2015
"XenoPort Shares Dive After Psoriasis Drug Study Results"
" Shares of Santa Clara, CA-based XenoPort were down 25 percent by midmorning Tuesday after the company announced positive preliminary results from a Phase 2 clinical trial of its oral psoriasis drug.
Although the biotech said it expects to begin Phase 3 trials of its drug, XP23829, in 2016, a high rate of gastrointestinal side effects may impede its efforts. XenoPort’s shares had initially been up 19 percent earlier Tuesday morning."
http://www.dddmag.com/news/2015/09/xenoport-s...dy-results
Things look bleak. There are some ugly side effects so what happened?
Imho Prurisol doesn't have to be worth 10 Billion. If Cellceutix had 47 million in the bank they could cover the B and K trials dilution free.
3/28/2016
"-Dr. Reddy's Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY) and XenoPort, Inc. (NASDAQ: XNPT) announced today that they have entered into a license agreement pursuant to which Dr. Reddy’s Laboratories will be granted exclusive U.S. rights for the development and commercialization of XenoPort’s clinical-stage oral new chemical entity, XP23829. Dr. Reddy’s Laboratories plans to develop XP23829 as a potential treatment for moderate-to-severe chronic plaque psoriasis"
"Under the terms of the agreement, Dr. Reddy’s Laboratories will receive exclusive U.S. rights to develop and commercialize XP23829 for all indications. In exchange for these rights, XenoPort will receive a $47.5 million up-front payment and an additional $2.5 million for transfer of certain clinical trial materials to Dr. Reddy’s Laboratories. XenoPort will also be eligible to receive up to $190 million upon the achievement by Dr. Reddy’s Laboratories of certain regulatory milestones, which could be achieved over a period of several years. In addition, XenoPort will be eligible to receive up to $250 million upon the achievement of commercial milestones, and up to mid-teens royalty payments based on potential net sales of XP23829 in the United States."
"“We are very pleased to announce this agreement with Dr. Reddy’s Laboratories,” said Vincent J. Angotti, Chief Executive Officer, XenoPort, Inc. “As one of our key objectives for 2016, we were interested in finding a strong partner that would recognize the opportunity of this innovative therapy that we believe will make a significant difference in the lives of psoriasis and MS patients. "
http://www.businesswire.com/news/home/2016032...-Licensing
They had multiple drugs in development, like Cellceutix, and did end up selling the entire company for what would put Cellceutix at around $4 a share.
5/23/2016
"XenoPort (XNPT) Stock Skyrockets, Arbor Pharmaceuticals Acquiring For $467 Million"
"NEW YORK (TheStreet) -- XenoPort (XNPT) shares are soaring 56.59% to $6.89 Monday on heavy trading volume, following the announcement that Arbor Pharmaceuticals will buy the biopharmaceutical company in a deal valued at around $467 million. "
https://www.google.com/amp/s/www.thestreet.co...llion.html
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